Identity
- Trade Name
- Provox StabiliBase (3 pcs) FDA UDI
- Generic Name
- Removable ambulatory appliance skin-adherent patch FDA UDI
- Device Name
- The Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System. FDA UDI
- Model / Reference
- 7299 FDA UDI
- Description
- The Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System. FDA UDI
Identifiers
- Catalog Number
- 7299 FDA UDI
- Primary DI / UDI-DI
- 07331791008023 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Removable ambulatory appliance skin-adherent patch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Removable ambulatory appliance skin-adherent patch
Provox StabiliBase (3 pcs) by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Removable ambulatory appliance skin-adherent patch.
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- Vitus — H R Pharmaceuticals, Inc. · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
- AURA — Branchpoint & Aura Development LLC · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 78474156-0d37-4335-ba37-dec0c819f1c4 36 fields · synced May 31, 2026